Carbamic acid, N-[[5-[[[2-[2-(dimethylamino)ethoxy]ethoxy]carbonyl]amino]-1,3,3-trimethylcyclohexyl]methyl]-, 2-[2-(dimethylamino)ethoxy]ethyl ester

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Part of the SNIF file, which was accepted by the Belgian national authority for NONS.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC Directive 2000/32, B.13/14

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

441-100-8

EC Name:

-

Cas Number:

351197-46-1

Molecular formula:

Hill formula: C24 H48 N4 O6 CAS formula: C24 H48 O6 N4

IUPAC Name:

2-[2-(dimethylamino)ethoxy]ethyl N-{[1,3,3-trimethyl-5-(9-methyl-2-oxo-3,6-dioxa-1,9-diazadecan-1-yl)cyclohexyl]methyl}carbamate

Method

Target gene:

his-operon, trp-operon

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli strain WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital / beta-Naphthoflavone induced rat liver S9 from 8-12 weeks old male Wistar HanIbm rats.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 33 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33 ... 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA1535 and TA100 without S9

Migrated to IUCLID6: 10 µg/plate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamine 50 and 10 µg/plate for TA1537 and TA98, respectively

Remarks:

TA1537 and TA98 without S9

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

WP2 uvrA without S9

Migrated to IUCLID6: 4 µl/plate

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene 2.5 µg/plate

Remarks:

TA 1535, TA1537, TA98 and TA100 with S9

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene 10 µg/plate

Remarks:

WP2 uvrA with S9

Results and discussion

Test results

Test results 1

Species / strain:

bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli strain WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli strain WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

TA1537 at 5000 µg/plate without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
No toxic effects, evident as a reduction in the number of
revertants, occurred in the test groups with and without
metabolic activation, except, for strain TA 1537 where a
minor toxic effect was observed at 5000 µg/plate without S9
mix in Experiment II.

No substantial increase in revertant colony numbers of any
of the five tester strains was observed following treatment
with the test substance at any dose level, either in the
presence or absence of metabolic activation. There was also
no tendancy of higher mutation rates with increasing
concentrations in the range below the genarally acknowledged
border of biological relevence.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative